DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitations is/are:
(Claim 6) “an automatic cannula insertion mechanism to propel the cannula bevel into the subject's skin.”
A review of the specification shows the following corresponding structure described in the specification for the above 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
(Claim 6) “an automatic cannula insertion mechanism to propel the cannula bevel into the subject's skin.”: As identified by the Specification, by incorporation of US 8,475,432, the following is recognized as the corresponding structure to the automatic cannula insertion mechanism: “The coil spring bias member 155 is configured to be in a compressed state, when the needle carriage 146 is in the retracted position (shown in FIG. 7), and an expanded state, when the needle carriage 146 is in the extended position (shown in FIG. 8). When in the compressed state shown in FIG. 7, the coil spring bias member 155 imparts a bias force on the needle carriage 146, in the direction of arrow 158. The needle carriage 146 may be held in the retracted position user (or other user) to selectively activate the needle inserter device by releasing the needle carriage and allowing the force of the bias member 155 to move the needle carriage 146 in the direction of the arrow 158. In the embodiment of FIG. 7, the actuation member 159 includes a rigid lever (or other structural member) that engages a stop surface 161 on the needle carriage 146 and is moveable in the direction of arrow 163 (by actuation of a manual lever, button or other operator, not shown) to a position in which the lever does not engage the stop surface 161, to allow the needle carriage 146 to move in the direction of arrow 158, under the force of the first bias member 155. While a manual lever, button or other operator may be employed to initiate movement of the actuation member 159, other embodiments may employ an automatic activation mechanism for moving the actuation member 159 (or otherwise release the needle carriage 146 for movement in the direction of arrow 158), such as, but not limited to, a mechanism that moves the actuation member 159 or otherwise releases the needle carriage for movement, in response to an expiration of a period of time from a sensor detecting the application of the delivery device (or components thereof) on the skin of user (or in another suitable location of operation).” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al (US 2009/0005665) (“Hayter”) as evidenced by Steil et al (US 2008/0183060) (“Steil”) in view of Paassilta et al (US 2010/0286507) (“Paassilta”).
Regarding Claim 1, while Hayter teaches a cannula insertion monitor (Abstract, [0075]-[0080], Figs. 7-9, 17), comprising:
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing (Figs. 4A-4B, [0057]-[0060] insertion tip 430 penetrates through skin into subcutaneous space, indicating a sharpened tip at distal end with the housing at the proximal end);
a single electrically insulating layer on the cannula (Fig. 4B, [0061] “Additionally, within the scope of the present disclosure, some or all of the electrodes 401, 402, 403 may be provided on the same side of the substrate 404 in a stacked construction as described above, or alternatively, may be provided in a co-planar manner such that each electrode is disposed on the same plane on the substrate 404, however, with a dielectric material or insulation material disposed between the conducting layers/electrodes.” the stacked insulating layers of the figure may be substituted with a design of co-planar electrodes with an insulating material between the co-planar electrodes, indicating a single co-planar insulating layer);
an electrically conductive distal electrode, surrounded partially by the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode, surrounded by the insulating layer ([0057]-[0060] working electrode 401 as distal electrode, counter electrode 403 as proximal electrode, [0061] in a co-planar fashion would be radially outward on an insertion tip);
a housing adapted to be positioned against a subject's skin (Fig. 4B), the housing having a sensor circuit electrically connected with the distal electrode and the proximal electrode (Fig. 2, processor 204) and detecting an electrical property of the tissue between said distal electrode and proximal electrode (Figs. 4 and 7, [0082] the measured signal is ADC count, where it would be known in the art that the ADC count from the inserted electrodes is a detection of an electrical property of the tissue between said distal electrode and proximal electrode. Steil provides the requisite explanation in [0074]-[0075] where a similar three electrode system penetrates a subject and the working electrode WRK corresponds to Hayter’s proximal electrode and the counter electrode CNT corresponds to Hayter’s distal electrode. Here it is explained that a circuit is completed between these electrodes on the cannula tip when inserted into the subject’s interstitial fluid. A set voltage is applied and an analog current signal is generated between the working electrode and the counter electrode, in relation to the electrical property of the tissue {e.g. the impedance of the interstitial fluid}. Due to Ohm’s law, where voltage is the product of current and impedance, a set voltage would necessitate proportional changes occur in the impedance in relation to changes to the current. Thus, the analog signal of Hayter will have current as the value converted to a digital signal for counts and the changing current acts as an electrical property of the interstitial fluid between the electrodes when a voltage is set as constant. This explanation is further supported as the background for Hayter’s measuring as Hayter’s desired measuring environment is also the subject’s interstitial fluid);
an alert mechanism responsive to the change in electrical property providing indication of insertion status of the cannula ([0082]-[0087], [0133]-[0114] user notification provided in response to sensor condition, the sensor condition may indicate improper insertion status, and insertion status is found from ADC count of electrodes. Therefore, the ADC count, representing the change in electrical property of the interstitial fluid, will provide an indication of insertion status of the cannula).
Hayter fails to teach the electrically conductive distal electrode disposed radially outward on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed radially outward on the insulating layer.
However Paasilta teaches a cannula insertion monitor (Abstract, [0028] needle insertion monitoring may be broadly combined with “a syringe, catheter, sampling device or similar device structures comprising a needle to be inserted into the organ system”), comprising:
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing (Figs. 1-2, [0028], [0030] needle 2 with a distal end with a sharpened tip / distal tip 3 and [0032]-[0033] a processing unit 5 may be integrated into a needle supporting structure as shown in Fig. 2, the processing unit 5 and the catheter/syringe/sampling device together make up the housing);
a single electrically insulating layer on the cannula (Fig. 5, [0083]-[0084] " When the material of the frame 15 is electrically conductive, it may be isolated from the electrodes 16, 18, 21, 22 by coating the frame 15 with a non-conductive coating and by arranging the electrodes on top of this, or, alternatively, with an electrode structure comprising an insulation material layer insulating the electrical parts of the electrode from the needle frame 15.” third needle embodiment utilizes a single non-conductive or insulating coating / layer);
The electrically conductive distal electrode disposed radially outward on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed radially outward on the insulating layer (Fig. 5, [0084] distal electrode 16 and proximal electrodes 18, 21, and 22 disposed radially outward on the needle, where the electrodes are on top of a non-conductive material over the needle frame 15 or have an insulating material between the electrodes and needle frame 15, indicating the electrode could be understood as on top of an intermediate insulating material placed on the needle frame 15);
a housing adapted to be positioned against a subject's skin (Figs. 1-2, the housing has the ability to be positioned against a subject’s skin), the housing having a sensor circuit electrically connected with the distal electrode and the proximal electrode and detecting an electrical property of the tissue between said distal electrode and proximal electrode (Fig. 2, [0028], [0032], [0037], [0073] pairs of electrodes used for measurement and electrically connect to sensor circuit / microprocessor 26, detecting bioimpedance of tissue between electrodes);
an alert mechanism responsive to the change in electrical property providing indication of insertion status of the cannula ([0041]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the insulation layer construction of Paassilta to the insulation layer of Hayter as Paassilta provides a detailed layout on how co-planar electrodes can be placed on an insertion tip utilizing a single insulating layer, enabling a standardized construction for the co-planar version of the insertion tip detailed in Hayter.
Regarding Claim 2, Hayter and Passilta teach the cannula insertion monitor according to claim 1, wherein the cannula is configured for insertion into a subject at an insertion site, and where the distal electrode and the proximal electrode are within an interstitial space of the insertion site when the cannula is fully seated in the insertion site (See Claim 1 Rejection, Hayter’s needle monitors glucose at an interstitial space, and thus would require electrodes in the interstitial space to ensure the needle is positioned at the desired monitoring area).
Regarding Claim 4, Hayter and Paassilta teach the cannula insertion monitor according to claim 1, wherein the change in electrical property is a change in current travelling between the proximal and distal electrodes (See Claim 1 Rejection).
Regarding Claim 5, Hayter and Passilta teach the cannula insertion monitor according to claim 1, wherein the electrically insulating layer is coated on the cannula, and the distal electrode and proximal electrode are coated on the electrically insulating layer (See Claim 1 Rejection, Paassilta [0080]-[0084] conductive material and insulative material may be applied by coatings).
Regarding Claim 6, Hayter and Passilta teach the cannula insertion monitor according to claim 1, and Paassilta teach a system further comprising an automatic cannula insertion mechanism to propel at least a portion of the cannula into the subject's skin ([0012]-[0013], [0090], [0097]-[0101], [0103]-[0106] master station attachment for attaching the needle system to the subject, actuating the needle’s insertion, where the insertion may be automated).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Hayter’s needle system to further include an automatic cannula insertion mechanism to propel at least a portion of the cannula into the subject's skin as taught by Paassilta as such an automated system “facilitates the injecting of the needle to the correct location and at a right angle to the skin or the mucosa. Also when the needle is injected into the tissue, needle movements assisted by a motor are significantly more precise than hand movements.” (Paassilta [0105]).
Regarding Claim 7, Hayter and Paassilta teach the cannula insertion monitor according to claim 1, and Hayter teaches wherein the alert mechanism comprises a signal transmitted to a remote blood glucose monitor or a remote medication delivery source ([0077], [0085]-[0087] where a receiver unit acts as remote blood glucose monitoring in the monitoring network of Hayter as noted in [0055]).
Regarding Claim 8, Hayter and Paassilta teach the cannula insertion monitor according to claim 1, wherein the alert mechanism consists of one or more selected from the group consisting of visible light, audible alarm, sensible vibration or a combination thereof, driven by the sensor circuit to provide separate indications when the cannula is properly inserted and when the cannula is not properly inserted (See Claim 1 Rejection, Hayter [0085] has a display alarm, [0062] alarm may be a “visual, audible or tactile cue” of successful needle placement or insufficient needle insertion and Paassilta [0041] display provides real-time feedback of penetration position).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter as evidenced by Steil in view of Paassilta and further in view of Ball et al (US 2013/0253447) (“Ball”).
Regarding Claim 3, while Hayter and Paassilta teach the cannula insertion monitor according to claim 1, their combined efforts fail to teach wherein said distal electrode is spaced from said proximal electrode a distance where a current does not flow between said proximal electrode and said distal electrode when the subject's skin is tented around the cannula
However Ball teaches a needle placement monitor (Abstract) comprising
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing ([0052] non-conducting needle 60 / cannula with a distal end with a sharpened tip as a needle and a proximal end positioned in a housing (Fig. 5A);
an electrically insulating layer on the cannula ([0052] several insulating layers 62, 64, 66 on needle 60);
an electrically conductive distal electrode on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode on the insulating layer ([0052] electrically conductive distal electrode 63 is on insulating layer 62 and an electrically conductive proximal electrode 65 is positioned proximally of the distal electrode 63 on the insulating layer 62);
a housing having a sensor circuit electrically connected with the distal electrode and the proximal electrode and detecting an electrical property of the tissue between said distal electrode and said proximal electrode ([0055]-[0056] electrical circuit judges needle 60’s insertion by any number of electrical properties between the electrodes at different positions along the needle);
an alert mechanism responsive to the change in electrical property providing indication of insertion status of the cannula ([0062] insertion placement judged and a cue / alert is provided to the subject, providing indication of insertion status of the cannula / needle); and
Wherein multiple electrodes are positioned so that electrical properties confirm positioning of the needle at a proper depth by expected characteristics of tissue (Figs. 6A-6D, [0056]-[0058] electrodes are positioned so the electrical properties confirm positioning of the needle at a proper depth by expected characteristics of tissue. If the skin is tented and the current does not flow properly between electrodes by the proximal electrode not being within tissue, the sensor circuit would detect this).
It would have been obvious to one of ordinary skill in the art at the time of the invention for the needle insertion monitoring electrodes in Paassilta to be spaced to identify proper insertion characteristics as taught by Ball to ensure the needle does not stop short or pass by the intended monitoring location of Hayter. Further, Paassilta confirms that electrode spacing may be adjusted based on desired outcome of tissue monitoring ([0086]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Paassilta and further in view of Goode, Jr. et al (US 2006/0258929) (“Goode”) as noted in Applicant IDS dated 12/20/2023.
Regarding Claim 9, while Hayter teaches an insertion monitor (Abstract, [0075]-[0080], Figs. 7-9, 17), comprising:
a housing adapted to be positioned adjacent an insertion site on a subject's skin (Fig. 4B, sensor 400’s housing with insertion tip 430 inserted into insertion site),
a cannula, catheter or probe having a distal end adapted for insertion into a subject's skin and a proximal end received in the housing (Figs. 4A-4B, [0057]-[0060] insertion tip 430 / cannula inserted through skin by a sharpened tip at distal end with the housing at the proximal end), the cannula, catheter, or probe having a single electrically insulating layer provided on the cannula, catheter, or probe (Fig. 4B, [0061] “Additionally, within the scope of the present disclosure, some or all of the electrodes 401, 402, 403 may be provided on the same side of the substrate 404 in a stacked construction as described above, or alternatively, may be provided in a co-planar manner such that each electrode is disposed on the same plane on the substrate 404, however, with a dielectric material or insulation material disposed between the conducting layers/electrodes.” the stacked insulating layers of the figure may be substituted with a design of co-planar electrodes with an insulating material between the co-planar electrodes, indicating a single co-planar insulating layer);
a detector including a pair of electrical sensing elements located on or adjacent to the cannula, catheter, or probe for detecting when the cannula, catheter or probe has reached a full penetration depth in the subject's skin ([0057]-[0060] working electrode 401 as distal electrode, counter electrode 403 as proximal electrode, [0082]-[0087], [0113]-[0114]); and
wherein the pair of electrical sensing elements comprise an electrically conducting distal electrode on the cannula, catheter, or probe disposed radially outward, surrounded partially by the insulating layer and an electrically conductive proximal electrode on the cannula, catheter, or probe, disposed radially outward, surrounded partially by the insulating layer ([0057]-[0060] working electrodes 401 as distal electrode, counter electrode 403 as proximal electrode, [0061] in a co-planar fashion would be radially outward on an insertion tip),
Hayter fails to teach a detector including a only two electrical sensing elements located on or adjacent to the cannula for detecting when the cannula, catheter or probe has reached full penetration depth in the subject's skin;
Wherein the only two electrical sensing elements consist of an electrically conducting distal electrode on the cannula, catheter, or probe disposed on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed on the insulating layer.
However Paassilta teaches a cannula insertion monitor (Abstract, [0028] needle insertion monitoring may be broadly combined with “a syringe, catheter, sampling device or similar device structures comprising a needle to be inserted into the organ system”), comprising:
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing (Figs. 1-2, [0028], [0030] needle 2 with a distal end with a sharpened tip / distal tip 3 and [0032]-[0033] a processing unit 5 may be integrated into a needle supporting structure as shown in Fig. 2, the processing unit 5 and the catheter/syringe/sampling device together make up the housing);
a single electrically insulating layer on the cannula (Fig. 5, [0083]-[0084] " When the material of the frame 15 is electrically conductive, it may be isolated from the electrodes 16, 18, 21, 22 by coating the frame 15 with a non-conductive coating and by arranging the electrodes on top of this, or, alternatively, with an electrode structure comprising an insulation material layer insulating the electrical parts of the electrode from the needle frame 15.” third needle embodiment utilizes a single non-conductive or insulating coating / layer);
The electrically conductive distal electrode disposed radially outward on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed radially outward on the insulating layer (Fig. 5, [0084] distal electrode 16 and proximal electrodes 18, 21, and 22 disposed radially outward on the needle, where the electrodes are on top of a non-conductive material over the needle frame 15 or have an insulating material between the electrodes and needle frame 15, indicating the electrode could be understood as on top of an intermediate insulating material placed on the needle frame 15).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the insulation layer construction of Paassilta to the insulation layer of Hayter as Paassilta provides a detailed layout on how co-planar electrodes can be placed on an insertion tip utilizing a single insulating layer, enabling a standardized construction for the co-planar version of the insertion tip detailed in Hayter.
Yet their combined efforts fail to teach the detector including only two electrical sensing elements located on or adjacent to the cannula for detecting when the cannula, catheter or probe has reached full penetration depth in the subject's skin;
Wherein the only two electrical sensing elements consist of an electrically conducting distal electrode on the cannula, catheter, or probe disposed and an electrically conductive proximal electrode positioned proximally of the distal electrode.
However Goode teaches a glucose sensing system (Abstract) comprising a penetrating cannula for measuring an interstitial fluid with a reference electrode, counter electrode, and working electrode ([0153]-[0155], [0190]-[0194]) and further teaches that a single electrode can act as both a reference electrode and counter electrode ([0199]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the counter electrode and reference electrode of Hayter into a single electrode as taught by Goode as a way to simplify the system by reduce the amount of required components.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Paassilta and further in view of Goode as evidenced by Steil.
Regarding Claim 15, Hayter, Paassilta, Goode teach the insertion monitor according to claim 9, wherein Hayter teaches an electrical current flows between said electrodes when the cannula, catheter or probe has reached full penetration depth in the subject's skin (Figs. 4 and 7, [0082] the measured signal is ADC count, where it would be known in the art that the ADC count from the inserted electrodes is a detection of current of the tissue between said distal electrode and proximal electrode. Steil provides the requisite explanation in [0074]-[0075] where a similar three electrode system penetrates a subject and the working electrode WRK corresponds to Hayter’s proximal electrode and the counter electrode CNT corresponds to Hayter’s distal electrode. Here it is explained that a circuit is completed between these electrodes on the cannula tip when inserted into the subject’s interstitial fluid. A set voltage is applied and an analog current signal is generated between the working electrode and the counter electrode, in relation to the electrical property of the tissue {e.g. the impedance of the interstitial fluid}. Thus, the analog signal of Hayter will have current as the value converted to a digital signal for counts. This explanation is further supported as the background for Hayter’s measuring as Hayter’s desired measuring environment is also the subject’s interstitial fluid).
Response to Arguments
Applicant's argument filed 1/12/2026 with respect to the resolution of the claim objections is confirmed. Their inclusion in the previous action dated 8/26/2025 was in error.
Applicant's arguments filed 1/12/2026 with respect to the 35 USC 103 rejections and specifically in regards to adding electrodes to measure an electrical property of tissue as taught in Paassilta. This argument is withdrawn.
Applicant's arguments filed 1/12/2026 with respect to the 35 USC 103 rejections applied in view of Hayter and Paassilta, has been fully considered, but is not persuasive in view of further consideration of Hayter. Specifically, Examiner reconsidered the electrical processing represented by Hayter’s ADC count and confirmed that this teaching is sufficient to teach the claim language. The Steil reference has been brought in to corroborate and confirm that the teachings of Hayter do in fact teach the detection of an electrical property of the tissue.
Applicant's amendments and remaining arguments, filed 1/12/2026, with respect to the 35 USC 103 rejections of Claim 9 have been fully considered, and are persuasive. The rejection is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hayter, Paassilta, and Goode.
Claims 2-8 and 15 remain rejected due to their dependencies on rejected independent claims 1 and 9.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner,
Art Unit 3791